Kornimate/medical-research-clean huggingface dataset:
effects of melatonin on insomnia symptoms in older adults

Conditions: Sleep Initiation and Maintenance Disorders

Summary: this study will determine whether melatonin tablets will increase the sleep of older adults with insomnia.

melatonin is a hormone secreted predominantly during the sleep period, suspected to have a strong link to the circadian sleep-wake cycle. melatonin is also available in a pill form and, when administered during the day, tends to have a sedative effect. clinical trials that have examined the nocturnal effects of melatonin have focused on patients of any age who have insomnia, regardless of their endogenous melatonin levels. data indicate, however, that individuals with low endogenous melatonin levels may be more responsive to exogenous melatonin. generally, melatonin levels decrease with age; therefore, older individuals with insomnia represent an ideal population in which to study the effects of exogenous melatonin on sleep. this study will provide older adults with insomnia melatonin tablets to determine whether the tablets will increase their sleep. participation in this study will last 10 weeks and will comprise overnight visits at 2 timepoints, the beginning of week 1 and the end of week 6. at study entry, participants will be admitted to the general clinical research center for a 3-night stay, beginning with an overnight urine screen to confirm low melatonin levels. participants will also be asked to begin a sleep diary documenting their sleep quality and quantity; the diary will be used throughout the study. during night 1 at the clinic, participants will have urine samples collected throughout the night. night 2 will be an adaptation night to allow participants to get used to their surroundings. on night 3, participants will have sensors attached to their bodies and a polysomnograph machine will be used to measure their sleep efficiency. participants with sleep efficiencies of 80% or higher will complete their study participation. participants with sleep efficiencies less than 80% will be randomly assigned to one of three study treatments daily for 6 weeks: high-dose melatonin (4.0 mg), low-dose melatonin (0.4 mg), or placebo. participants will have study visits at weeks 1, 3, and 6 to monitor for adverse events. after 6 weeks, participants will have 2 more overnight clinic visits that will be identical to nights 2 and 3 from the beginning of the study. sleep questionnaires, cognitive tests, and psychomotor tests will be used to assess participants at the beginning of the study, after 6 weeks, and at the end of the study. one month after the end of the study, participants will have a follow-up visit to be reassessed for adverse events.

Eligibility criteria:
inclusion criteria: * history of insomnia * low melatonin levels at study entry exclusion criteria: * history of sleep apnea (temporary cessation of breathing during sleep) * diagnosis of restless legs syndrome * current alcohol or substance abuse * dementia * anemia * liver disease * leukemia or lymphoma * asthma

Keywords: aged sleep insomnia melatonin neurobehavioral manifestations circadian rhythms human polysomnography elderly
learning to resist the urge: inhibition training in abstinent patients with alcohol use disorders

Conditions: Alcohol Dependence

Summary: the study aims to investigate the effects of a short computerized training as a therapeutic add-on to standard therapy in patients with alcohol-use disorder.

therapeutic interventions to treat alcohol use disorders (aud) still need to be improved. a novel alcohol-specific inhibition-training seems to be a promising new intervention. in this study, recently abstinent patients with aud attending an inpatient treatment program will be randomly assigned to one of two alcohol-specific inhibition-training groups (varying in go/nogo-ratio) or to a control condition. besides the effects on drinking behavior, inhibition and implicit attitudes, the investigators expect the training to influence neurophysiological reactivity to alcohol related stimuli. a subgroup of patients will therefore additionally undergo eeg recording so that the neurophysiological effects of the training can be assessed and related to clinical outcome. furthermore, since training effects rely on learning processes, the influence of endogenous cortisol level (a consolidation-enhancer which peaks in the morning) on training outcome will be examined by the variation of daytime of the training. all patients' inhibitory control and implicit associations towards alcohol will be measured before and after training. the training effects will be examined on proximal outcome variables (e.g. implicit associations, inhibitory control, abstinence related self-efficacy, craving) and on distal outcome variables at 3-, 6- and 12- months follow-up (e.g. percent abstinent days (primary outcome)).

Eligibility criteria:
inclusion criteria: * abstinent patients with an alcohol use disorder in the 12-week inpatient program of the clinic südhang or the forel clinic, * abstained from alcohol for at least 4 weeks (in relation to timepoint when training will start), * informed consent as documented by signature. exclusion criteria: * other main psychiatric diagnosis than alcohol use disorder (comorbidity is allowed if the alcohol use disorder is to be considered the main diagnosis), * other severe substance use disorder (except nicotine), even as secondary diagnosis * neurocognitive problems (e.g. korsakoff syndrome), * current medical conditions excluding participation (e.g. acute infectious disease), * inability to read and understand the participant's information, * enrolment of the investigator, his/her family members, employees and other dependent persons.

Keywords: alcohol use disorders inhibition eeg cortisol training clinical outcome measures
studying the effects of phentermine on eating behavior

Conditions: Obesity

Summary: the goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.

this study aims to explore whether short-term measures of eating behavior can be related to later, longer-term weight loss. in a double-blind, randomized fashion, participants will be asked to take study medication for three weeks: one week of phentermine and two weeks of placebo. at the end of the first and third weeks, participants will be asked to participate in a range of eating behavior studies. following this three-week, double-blind phase, participants will be offered 6 months of open treatment for weight loss.

Eligibility criteria:
inclusion criteria: * bmi between 30-40kg/m2 * stable weight (+5 lbs) for a minimum of 3 months * systolic blood pressure \<140mm hg * diastolic blood pressure \<90 mm hg * pulse \<95 beats per minute * english language proficiency exclusion criteria: * previous unsuccessful trial of phentermine * prior adverse reaction to phentermine * on any antidepressant medications,especially monoamine oxidase inhibitors(maoi) * history of neurological disorder (e.g. dementia) * history of moderate or severe head injury * current or past history of coronary artery disease * current or past history of stroke or transient ischemic attack * current or past history of heart arrhythmias * current of past history of congestive heart failure * current or past history of peripheral artery disease * current or past history of liver disease * current or past history of kidney disease * uncontrolled diabetes mellitus (type i or ii) * narrow-angle glaucoma * hypo- or hyper-thyroidism not adequately treated * on medications (prescribed or otc) known to affect appetite (e.g. diet pills), weight, or metabolism * current or past history (within the past 12 months) of major depression * current or past history (past 12 months) of alcohol or drug abuse or dependence * current or past history (lifetime) of amphetamine abuse or dependence * known history of learning disorder or developmental disability * current or past attention deficit hyperactivity disorder (adhd) * pregnancy, planning to become pregnant, or lactation within the previous 6 months * waist circumference greater than 188cm * indwelling metallic object (e.g., pacemaker,pump), non-removable metal jewelry, medicinal patch or recent metallic ink tattoo * significant claustrophobia * current or past history of anorexia nervosa,bulimia nervosa (within the past 12 months) or binge eating disorder (within the previous 6 months)
bone mineral density in patients with sarcoidosis

Conditions: Sarcoidosis; Osteoporosis Risk

Summary: to assess the frequency and risk factors of decreased bone mineral density (bmd) and vertebral fractures in danish patients with sarcoidosis.

an increased risk of bone fracture has been found in patients with sarcoidosis. some data showed that the risk of fracture was limited to patients treated with glucocorticoid but data are conflicting and not all studies can prove an increased risk of fracture or bone mineral loss in sarcoidosis.

Eligibility criteria:
inclusion criteria: * diagnosis of sarcoidosis * signed informed consent exclusion criteria: * inability or unwillingness to adhere to the study * inability to give informed consent
coronary sinus reducer objective impact on symptoms, mri ischaemia and microvascular resistance

Conditions: Refractory Angina

Summary: orbita-cosmic is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (csr). the investigators will compare the effects of csr versus placebo on myocardial perfusion on mri, exercise time and symptoms in 50 participants with refractory angina and ischaemia.


Eligibility criteria:
inclusion criteria: * stable coronary artery disease (cad) not eligible for percutaneous coronary intervention (pci) or coronary artery bypass graft surgery (cabg) * evidence of ischaemia on stress perfusion cmr * angina - canadian cardiovascular society class ii-vi on maximal medical therapy exclusion criteria: * age\<18 years * pregnancy * inability to consent * recent acute coronary syndrome (3 months) * recent revascularisation (6 months) * permanent pacemaker or defibrillator leads in the right heart * severe left ventricular impairment (\<25%) * indication for cardiac resynchronisation therapy (crt) * right atrial pressure ≥15mmhg * life expectancy \<1 year * severe renal impairment (egfr\<15) * contraindication to cmr * contraindication to adenosine * ischaemia isolated to inferior wall * ongoing participation in a separate interventional study
the effect of sweet orange aromatherapy on anxiety and pulse level of nurse students

Conditions: University Students

Summary: this randomized controlled study examined the effect of sweet orange essential oil aromatherapy on reducing anxiety experienced by nursing students during the iv cannulation process. first-year nursing students from a university in eastern turkey participated in the study. according to the sample size determined by g\*power analysis, 100 students were randomized, and the study was completed with 47 students in the experimental group and 48 students in the control group. all students were taught iv cannulation skills theoretically and practically. subsequently, students in the experimental group performed iv cannulation on real patients after receiving aromatherapy. data were collected using a personal information form, a pulse monitoring form, and the state-trait anxiety inventory (stai).

this randomized controlled trial aimed to evaluate the effectiveness of sweet orange essential oil aromatherapy in reducing anxiety among nursing students during the iv cannulation procedure. the study was conducted with first-year nursing students enrolled in the nursing department of a university in eastern turkey. the sample size was determined using g\*power analysis, and a total of 100 students were randomized into two groups. the study was completed with 47 students in the experimental group and 48 students in the control group. all participants received standardized theoretical and practical training on iv cannulation. following the training, students in the experimental group were exposed to sweet orange essential oil aromatherapy before performing iv cannulation on real patients, while those in the control group proceeded with the procedure without aromatherapy intervention. data collection tools included a personal information form, a pulse monitoring form to track physiological responses, and the state-trait anxiety inventory (stai) to assess anxiety levels. the study aimed to determine whether aromatherapy could serve as an effective non-pharmacological strategy for alleviating procedural anxiety among nursing students.

Eligibility criteria:
inclusion criteria: * being actively enrolled in school, not having performed an iv cannulation before, taking the basic principles and fundamentals in nursing i course, and not having any health issues that would prevent inhaling sweet orange oil. exclusion criteria: * not volunteering to participate in the study, not being actively enrolled in school, and having any health issues that would prevent inhaling sweet orange oil.

Keywords: sweet orange aromatherapy nursing students iv cannulation skill anxiety heart rate
acupuncture as adjuvant therapy for glaucoma - protocol for a randomized controlled trial

Conditions: Glaucoma; Acupuncture; Intraocular Pressure

Summary: this clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. a randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. this study aims to provide a reference for future clinical treatment guidelines.

this clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. it is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. participants will be randomly divided into two groups: ophthalmic acupoint treatment group and non-ophthalmological acupoint control group. participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'de qi' sensation. conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'de qi' sensation. both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. on each visit, intraocular pressure, blood pressure, and heart rate will be assessed. questionnaires of glaucoma symptom scale (gss) and the glaucoma quality of life-15 (gql-15) will be performed. the data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.

Eligibility criteria:
inclusion criteria: 1. primary open angle glaucoma diagnosed at least 3 months ago. 2. diagnosed with mild or moderate open angel glaucoma. 3. use 1 or 2 kinds of glaucoma drugs. 4. age ≥ 20 years old. 5. participants sign the informed consent and cooperate with the experimental procedures. exclusion criteria: 1. accept any ophthalmic laser or surgery within one year. 2. high myopia. 3. use of any drugs that affect intraocular pressure. 4. visual acuity with correction lower than 0.2. 5. previous or existing uveitis or retinopathy. 6. unable to receive acupuncture treatment continuously or allergic to acupuncture needles. 7. pregnancy or breastfeeding. 8. refusal to sign the informed consent form.

Keywords: glaucoma acupuncture
factors influencing the deterioration from cognitive decline of normal aging to dementia among nursing home residents

Conditions: Dementia

Summary: background: a dearth of differential research exists regarding the determinants of mild cognitive impairment (mci) and moderate cognitive impairment or dementia among nursing home residents. this study aimed to identify and examine the association between medical factors (number of comorbidities, hospitalization, disability, depression, frailty and quality of life) and moderate cognitive impairment or dementia in nursing homes residents. methods: a cross-sectional design was used in this study. convenience sampling of 182 participants was conducted in nursing homes located in the central part of jordan. montreal cognitive assessment (moca) was used to screen both mci and moderate cognitive impairment or dementia. bivariate analysis, including t-test and anova test, and logistic and linear regression models were used to examine and identify the medical factors associated with moderate cognitive impairment or dementia compared to mild cognitive impairment.


Eligibility criteria:
inclusion criteria: * jordanian participants, aged 60 years and older, and living in nursing homes exclusion criteria: * neurological disorders, such as stroke or brain injury
pregnancy outcomes with a gnrh antagonist protocol versus gnrh-agonist protocol in icsi cycles

Conditions: Infertility

Summary: cycles with gnrh agonist and gnrh antagonist were compared and main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates, were analized.

160 women were equally divided between a gnrh antagonist protocol (group 1) versus a gnrh agonist protocol (group 2) in icsi cycles. the trial was conducted between september 2005 and december 2006. the mean age in both groups was 32 (range 22-40). the main outcome measures were the number of oocytes retrieved, injected and fertilized, embryos transferred, and clinical pregnancy and miscarriage rates.

Eligibility criteria:
inclusion criteria: * infertility couples, absence of endometriosis (confirmed by a previous surgical procedure to investigate infertility), polycystic ovarian syndrome, fsh levels \< 12 iu/l, basal levels of estradiol \< 20 in the group submitted to the agonist protocol and beginning of stimulation on day 2 in group submitted to antagonist protocol, in the absence of ovarian cysts on the endovaginal ultrasound exclusion criteria: * use of exogenous lh during stimulation

Keywords: gnrh antagonist gnrh agonist icsi miscarriage rate pregnancy outcome
whole soy and daidzein on reduction of blood pressure in postmenopausal chinese women

Conditions: Hypertension

Summary: the investigators hypothesize that whole soy or purified daidzein alone could reduce blood pressure and cvd risks in equol-producing menopausal chinese women.

hypertension is an important risk factor for cardiovascular diseases. substantial evidence has also shown that prehypertension \[systolic blood pressure (bp) 120-139 mm hg or diastolic bp 80-89 mm hg\] is the strongest predictor of incident hypertension and is associated with elevated risk of cardiovascular diseases. thus, prehypertension and its progression to hypertension have enormous public health implications. soybean contains many beneficial components, among which isoflavones have received most research attention. recently researchers have investigated their influences on vascular functions but only a handful of studies have focused on bp reduction as the primary outcome.the role of whole soy or daidzein on bp is yet unclear. the investigators hypothesize that whole soy (soy flour) or purified daidzein alone could reduce bp,and decrease cvd risks in menopausal women with prehypertension or initial untreated hypertension. the investigators propose to perform a 24-week double-blind, randomized, placebo-controlled trial in postmenopausal women with prehypertension or stage 1 hypertension. the primary objective is to verify if whole soy (soy flour) or purified daidzein alone has anti-hypertensive effects at a dosage of habitual high soy intake.

Eligibility criteria:
inclusion criteria: * postmenopausal chinese women with prehypertension or stage 1 hypertension exclusion criteria: * medical treatment for blood pressure or lipids reduction hormones replacement therapy in recent 3 months, chronic renal or hepatic diseases
long-term extension study of bema™ fentanyl

Conditions: Respiratory Depression

Summary: this study is designed to provide continued access to bema fentanyl for those subjects who previously participated in fen-202 and who wish to continue using bema fentanyl for the treatment of their breakthrough cancer pain.

this was an open label, long-term, extension study designed to provide continued access to ema fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in fen-202, the long term safety study used for worldwide registration. patients were followed in an outpatient setting. use of bema fentanyl and occurrence of serious adverse events (saes) were monitored. throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of bema fentanyl.

Eligibility criteria:
inclusion criteria: 1. previously qualified for and participated in study fen-202 for at least 2 weeks, 2. wish to continue using bema fentanyl for treatment of breakthrough pain episodes, and 3. provide signed informed consent at screening prior to any study procedures. exclusion criteria: 1. they have developed a new medical condition after initial enrollment in fen-202 which, in the opinion of the investigator, would preclude safe and appropriate use of bema fentanyl or participation in this study, or 2. there is evidence of improper use of the study drug.

Keywords: chronic pain ventilatory response to hypercapnia (vrh)
changes in cardiac output during delayed umbilical cord clamping

Conditions: Cardiac Output, Low

Summary: recently, the american college of obstetricians and gynecologists (acog) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. this delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. the purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition


Eligibility criteria:
inclusion criteria: * healthy full term infants * delivered by vaginal birth * estimated gestational age of 37+0to 41+6 weeks corrected gestational age exclusion criteria: * multiples * known fetal anomalies (including cardiac defects). * instrumentation during delivery (forceps or vacuum) * non-reducible nuchal cord during delivery. * any maternal or neonatal indication requiring immediate cord clamping.

Keywords: delayed cord clamping
attention bias modification training in social phobia/social anxiety disorder

Conditions: Social Phobia

Summary: a study investigating six different versions of a computerized attention bias modification internet program in the treatment of social phobia / social anxiety disorder.

previous studies have shown that individuals with social phobia have attention biases, often focusing on aversive stimuli or avoiding aversive stimuli. computerized training programs have been developed to implicitly direct the users attention towards a neutral, non-threatening stimuli. in this study, such a program will be compared with a program that implicitly directs the users' attention towards threatening cues. pre/post-measurements will be compared in a sample of individuals that meet diagnostic criteria of social anxiety disorder. participants will be randomized to one of three groups, receiving one of the two variants of the attention bias modification program or a control training program.

Eligibility criteria:
inclusion criteria: * participants must meet criteria for social phobia using the international classification system diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv). * comorbidity is allowed, but social phobia must be the primary diagnosis. exclusion criteria: * below 18 years old. * individuals who are suicide prone will be excluded from the study.

Keywords: social phobia anxiety